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Title Slide
A Medicated Population
Historical Perspectives
Newer Information
Postmarketing Surveillance Challenges
Why Postmarketing Surveillance?
Types of ADRS
PPT Slide
How Are Drug Safety Risks Managed?
Traditional Interventions
Potential Interventions
Draft Report to the FDA Commissioner by HHS Office of Inspector General
Report to the FDA Commissioner by Task Force on Risk Management
Components of a Comprehensive Postmarketing Program
Surveillance Components of a Comprehensive Postmarketing Program
x
Passive Reporting - Voluntary Reporting
Count of All Domestic + Foreign Cases By Type of Report By Year - 1985 to Present
AERS
Electronic Submission Pilot Program Participants
New Methods - Data-Mining
ðóeÈóe
Current resources
Active Surveillance -- Periodic Solicitation of Case Reports
Medication Errors -- Postmarketing Evaluation
Medication Errors -- Premarketing Evaluation Proposal
Relevant Websites
MedWatch Listserv
MedWatch Homepage (www.fda.gov/medwatch)
Ralph Lillie, RPh, MPH
Director, Office of Information Technology
December 8, 1999
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Last update: July 13, 2005
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